首页|966例新的和严重药品不良反应回顾性分析

966例新的和严重药品不良反应回顾性分析

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目的 促进临床安全用药。方法 检索山东省日照市 2021 年 11 月至 2022 年 11 月上报至国家药品不良反应(ADR)监测系统已完成评价,且已确定为新的和严重ADR报告,采用Excel软件对 966 例报告中患者性别和年龄,给药途径,药品分类,累及器官/系统及临床表现,转归,上报人员职业等项目进行回顾性分析。结果 共上报ADR 4 545 例,其中新的和严重ADR 966 例(21。25%)。女性多于男性(55。80%比 44。20%),>60 岁老年患者(49。90%)最多;给药途径以静脉滴注为主(58。28%);ADR共涉及 424 种药品,主要由抗感染药物(26。50%)、抗肿瘤药物(19。67%)和中药制剂(17。08%)引发,分别涉及药品 75 种(17。69%)、47 种(11。08%)、111 种(26。18%);临床表现主要累及消化系统(24。12%)、全身性损坏(20。44%)、皮肤及其附件损害(17。60%)和血液系统(14。10%);转归主要为好转(55。07%)或痊愈(40。48%);上报人员以医师为主(92。86%)。结论 医疗机构应加强对患者特别是老年患者临床用药ADR的监测和上报工作,及时发现并正确处理,以提高用药安全性。
Retrospective Analysis of 966 New and Severe Adverse Drug Reactions
Objective To promote medication safety in the clinic.Methods The reports submitted by Rizhao City,Shandong Province from November 2021 to November 2022 to the National National Adverse Drug Reaction(ADR)Monitoring System,which have been evaluated and identified as new and severe ADR reports were searched.Retrospective analysis was conducted on patients′ gender and age,administration route,drug classification,involved organs/systems and clinical manifestations,outcomes,and occupations of reporting personnel in the reports by the Excel software.Results A total of 4 545 cases of ADRs were reported,including 966 new and severe ADR reports(21.25%),with more females than males(55.80%vs.44.20%),and the most number of ADRs accurred in elderly patients over 60 years old(49.90%).The main administration route was intravenous infusion(58.28%).ADR involved 424 drugs,mainly induced by anti-infective drugs(26.50%),anti-tumor drugs(19.67%),and traditional Chinese medicine preparations(17.08%),involving 75 kinds of drugs(17.69%),47 kinds of drugs(11.08%),and 111 kinds of drugs(26.18%),respectively.The clinical manifestations mainly involved the digestive system(24.12%),systemic damage(20.44%),skin and accessories(17.60%),and blood system(14.10%),with the main outcome being improvement(55.07%)or recovery(40.48%).The reporting personnel were mainly physicians(92.86%).Conclusion Medical institutions should strengthen the monitoring and reporting of ADRs of clinical medication in patients,especially elderly patients,in order to timely find and handle them correctly and improve medication safety.

new adverse drug reactionssevere adverse drug reactionsmedication safetypharmacovigilance

房靖祥、吴瑞强、刘云

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新的药品不良反应 严重药品不良反应 安全用药 药物警戒

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(7)
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